Associate Director, Process Engineer

At Heron, we are unwavering in our commitment to improve the lives of patients. We aim to advance the therapeutic standard of care for patients through a portfolio of best-in-class therapies in Acute Care and Oncology that bring together our innovative science and technologies with well-known pharmacology to deliver medicines that matter.

We are excited to be growing and adding to our amazing team! Come join us!

POSITION: ASSOCIATE DIRECTOR, PROCESS ENGINEER

The primary duties involve the management of drug product manufacturing activities at contract manufacturing organizations (CMOs). The successful candidate has expertise in parenteral drug manufacturing, aseptic process validation, technology transfer, process development, change management, and an ability to coordinate multiple projects at different CMO locations.

This position must be located in either Minneapolis, MN (remote) near one of the CMOs or in Cary, NC (hybrid).

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Direct, oversee, and/or develop drug product manufacturing processes at CMOs in support of clinical phase through commercial production. Act as company liaison, including person in plant, for activities at CMO sites.
• Collaborate with internal Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain teams to align on company product development and production goals.
• Collaborate with Quality organizations to assure cGMP standards and agreed upon Quality performance/improvement deliverables are achieved.
• Define development pathway for CMO activities to meet corporate goals. Develop contingency plans and/or risk mitigation strategies and allocate resources as appropriate to ensure project milestones are achieved.
• Author and/or review internal and CMO documents as the manufacturing subject matter expert for protocols, reports, master batch records and other relevant documents.
• Responsible for manufacturing process development, implementation, and continuous improvement to improve efficiency and achieve consistent process performance. Manage process validations (IQ/OQ/PQ) at CMO.
• Prepare performance objectives and metrics for supplier and company. Monitor and report on process trends of important performance indicators.
• Deliver frequent verbal and/or written communications for internal meetings and external collaborators.

REQUIREMENTS:

• Requires a degree in Biology, Pharmacy, Chemistry or Engineering (Chemical or Mechanical): Bachelor's / Master's degree with 10+ years of experience or PhD degree with 8+ years of experience.
• Experience in management of drug product production techniques and processing at CMO sites. Proficiency with aseptic drug product techniques to produce sterile products in vials and pre-filled syringes is highly desired.
• Strong knowledge and demonstrated practice of relevant ICH, cGMP, and ISO guidelines.
• Detail-oriented with strong written and oral communication skills.
• Thrives working with others in a multidisciplinary team environment.
• Ability to independently troubleshoot problems and design, develop, and execute projects with minimal supervision.
• Ability to travel 15 - 40% within and outside of the USA, as required to meet project objectives.

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.